Psychotropic Medications in Children and Adolescents: Guide for Use and This document was developed by Community Care of North Carolina with the assistance of the Medication Management Workgroup of the Fostering Health NC initiative, a project of the NC Pediatric Society (www.ncpeds.org/fosteringhealthnc). The information contained in this guide is not intended to substitute or act as medical advice. If you have any questions about a medication prescribed to a child or adolescent in your care, contact the prescriber or a licensed medical professional. Definition of Psychotropic Medication: Medication used in the treatment of mental illnesses and capable of affecting the mind, emotions, and. Author: Jerry McKee Pharm. D., M.S., BCPP Medical Affairs- Director of Pharmacy Community Care of North Carolina 2300 Rexwoods Drive, Suite 100 Raleigh, NC 27607 919-516-8118 jmckee@n3cn.org Use of this Information: The tables below offer information for care managers and foster and resource parents to use when they want to learn more about certain psychotropic medications. Specific information is outlined including the therapeutic class, brand and generic names, FDA approved uses, common evidence-based uses, potential side effects, and medication-specific safety/effectiveness monitoring necessary when prescribed to a child or adolescent. Because few medications have been FDA approved for use in children 5 years of age and under, there is a column in the table that lists the FDA approved status and age ranges for the approved uses of each medication. This guide also provides a colorcoded quick reference guide for each medication (Appendix A), questions that a foster or resource parent should ask a prescriber (Appendix B), and a glossary of terms (Appendix C). Information provided in this document is based on Psychotropic Medication Utilization Parameters for Children and Youth in Foster Care, 5 th Version- Texas Dept. of FPS; Lexicomp. Table of Contents: Page(s): ADHD Medications 2 Depression & Anxiety Medications 3-4 Second Generation Antipsychotic Medications 5-6 Mood Stabilizer Medications 7-9 Sleep Medications 10-11 Appendix A: Color-Coded Psychotropic Medications 12-13 Appendix B: Questions to Ask the Prescriber 14 Appendix C: Glossary of Terms 15-16 Page 1
Amphetamine Mixed Salts Adderall, Adderall XR 3 and older; 6 and older (XR) Dextroamphetamine Dexedrine, Zenzedi 3 and older Lixdexamfetamine Vyvanse 6 and older Methylphenidate Ritalin, Ritalin SR, 6 and older Ritalin LA, Methylin, Methylin ER, Metadate ER, Metadate CD, Quillivant XR, Concerta Dexmethylphenidate Focalin, Focalin XR 6 and older Generic Name ADHD Medications Stimulants None Increased blood pressure Increased heart rate Tics (abnormal movement most often in the face) Weight loss Loss of appetite Sleep disturbance Irritability/anxiety Other ADHD Medications Atomoxetine Strattera 6 and older None Increased blood pressure Increased heart rate Sleep disturbance Stomach discomfort Dizziness Clonidine Catapres, Kapvay IR form not FDA approved for children; ER form ages 6-17 Guanfacine Tenex, Intuniv 6 and older None None Low blood pressure Decreased heart rate Feeling faint or dizzy Feeling tired Height Weight Heart rate Blood pressure Height Weight Heart rate Blood pressure Heart rate Blood pressure Page 2
Depression & Anxiety Medications SSRIs (Selective Serotonin Reuptake Inhibitors) Citalopram* Escitalopram Celexa Lexapro 18 and older 12-17 for depression Obsessive Compulsive Disorder (OCD) Fluoxetine Prozac 8 and older for depression Paroxetine* Paxil 18 and older Fluvoxamine Luvox 8 and older for OCD Sertraline Zoloft 6 and older for OCD Vilazodone* Vibryd 18 and older *not approved for children and adolescents Generic Name Weight gain Headache Stomach discomfort Sleep disturbance Flu-like symptoms if stopped too quickly Abnormal generalized bleeding risk SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) Venlafaxine* Effexor, Effexor XR 18 and older Obsessive Compulsive Duloxetine Cymbalta 18 and older Disorder (OCD) Desvenlafaxine* Pristiq 18 and older Clomipramine Anafranil 10 and older for OCD Levmilnacipram* Fetzima 18 and older *not approved for children and adolescents Weight gain Headache Seizures Hyponatremia/low blood sodium levels Hepatic toxicity/liver damage Skin reactions Stomach discomfort Sleep disturbance Flu-like symptoms if stopped too quickly Elevated blood pressure/pulse Abnormal bleeding risk Height Weight Sodium levels in the blood Height Weight Blood pressure during initial dose adjustment and periodically thereafter Hepatic function testing baseline and periodically CBC and EKG baseline and periodically Page 3
Depression & Anxiety Medications Other Depression & Anxiety Medications Mirtazapine* Remeron 18 and older None Vortioxetine* Brintellix/Trintellix 18 and older None Abnormal bleeding risk Weight gain Headache Hyponatremia Stomach discomfort Sleep disturbance Flu-like symptoms if stopped too quickly Dizziness Liver toxicity, seizures, and white blood cell decrease risk with mirtazapine Bupropion* Wellbutrin, Wellbutrin XL/SR *not approved for children and adolescents 18 and older ADHD Increased blood pressure, elevated pulse Seizure risk Discontinuation Syndrome if stopped abruptly Appetite suppression Height Weight Blood pressure-during titration and periodically Hepatic function testing baseline and periodically CBC baseline and periodically Cholesterol testing at baseline and periodically Blood pressure and pulseduring titration and periodically Seizure risk with other medications Weight Page 4
Second Generation Antipsychotic Medications Aripiprazole Abilify Approved for children 10 and older for bipolar disorder, manic or mixed episodes. Approved for adolescents 13 to 17 -for schizophrenia and bipolar disorder. Approved for 6 to 17 year olds for irritability associated with autistic disorder Quetipine Seroquel, Seroquel XR Approved for adolescents 13 and older for schizophrenia. Approved for young adults 18 and older for bipolar disorder. Approved for 10 to 17 years olds for manic and mixed episodes of bipolar disorder Olanzapine Zyprexa ETC. 18 and olderschizophrenia; 13 to 17- second line treatment for manic or mixed episodes of bipolar disorder Risperidone Risperdal ETC. 13 and olderschizophrenia; 10 and older- bipolar mania and mixed episodes; 5 to 16- irritability associated with autism Approved for bipolar mania or mixed episodes (10-17 years); schizophrenia (13-17 years); irritability associated with autism spectrum disorder (6-17 years) Approved for bipolar mania (10-17 years); schizophrenia (13-17 years) Approved for bipolar mania or mixed episodes and schizophrenia (13-17 years) Approved for schizophrenia (13-17 years); bipolar mania or mixed episodes (10-17 years); irritability associated with autism spectrum disorder (5-16 years) Page 5 Acute Extrapyramidal symptoms Tardive dyskinesia Neuroleptic malignant syndrome Hyperglycemia, diabetes mellitus Elevated prolactin, gynecomastia, amenorrhea Weight gain Dyslipidemia CBC abnormalities Lowered seizure threshold Dysphagia Hyperthermia/lowered heat tolerance Cognitive impairment (confusion and/or inability to focus that differs from baseline) Same as previous page Fasting plasma glucose or hemoglobin A1c and lipids at baseline, 3 months, then every 6 months EKG- baseline and periodically CBC- baseline and periodically Blood pressure each visit Pulse each visit Weight/height/BMI at each visit EPS evaluation baseline and weekly until dose stabilized Tardive dyskinesia evaluation every 3 months Clozapine-requires REMS Vision assessment for changes annually Sexual function-at each visit for first 12 months then every 6 months Same as previous page
Second Generation Antipsychotic Medications Clozapine* Clozaril, FazaClo, 18 and older None Versacloz Asenapine Saphris 18 and older Approved for acute treatment of bipolar mania and mixed episodes (10-17 years) Iloperidone* Fanapt 18 and older None Paliperidone Invega 12 and older Approved for treatment of schizophrenia (12-17 years) Ziprasidone* Geodon 18 and older None Lurasidone* Latuda 18 and older None Brexpiprazole* Rexulti 18 and older None *not approved for children and adolescents Page 6
Carbamazepine Divalproex Sodium Tegretol, Tegretol XR, Epitol, Carbatrol, Equetro Depakote, Depakote ER, Depakote Sprinkles Mood Stabilizer Medications Not FDA approved for bipolar disorder or mood lability in children and adolescents* Not FDA approved for bipolar disorder or mood lability in children and adolescents* FDA approved for seizures-all ages FDA approved for seizures-ages 2 and older Stevens-Johnson Syndrome (severe rash) Aplastic anemia Suicidal ideation Teratogenicity CBC abnormalities Hyponatremia Induces metabolism of many other medications and decreases their efficacyincluding oral contraceptives Withdrawal seizures Ataxia/dizziness Sedation Slurred speech Nausea/vomiting Transient increase in liver function tests up to hepatotoxicity Pancreatitis Bruising Urea cycle disorders Teratogenicity Suicidal ideation CBC abnormalities Hyperammonemia Multi-organ hypersensitivity reaction Polycystic ovary syndrome Weight gain Nausea/vomiting Alopecia Withdrawal seizures Baseline then every 6-12 months CBC with differential, comprehensive chemistry panel, EKG Pregnancy test at baseline Drug levels every 1-2 weeks for initial 2 months, then every 3-6 months Baseline then every 6 months CBC with differential, comprehensive chemistry panel Pregnancy test at baseline Drug levels weekly for 2-3 weeks, then every 3-6 months Weight Page 7
Lithium Eskalith, Eskalith CR, Lithobid Mood Stabilizer Medications Approved for adolescents age 12 and older for bipolar disorder Approved for manic episodes and bipolar maintenance for children >=12 years Narrow therapeutic index drug Chronic renal impairment Polyurea/polydipsia Tremor of hands, upper extremities Diarrhea Nausea/vomiting (take with food) Lethargy, weakness, confusion Hypothyroidism Teratogenicity Baseline then every 6-12 months CBC with differential, comprehensive chemistry panel, EKG, thyroid function testing Pregnancy test at baseline Drug levels after 1-2 weeks of treatment or each dosage change, monthly for 3 months, then every 3-6 months Lamotrigine Lamictal Not FDA approved for bipolar disorder or mood lability in children and adolescents* FDA approved for seizures ages 2 and older Potential Stevens-Johnson Syndrome (severe rash)-risk increases with rapid titration Multi-organ hypersensitivity reaction Suicidal ideation Dizziness/Ataxia Headache Nausea/vomiting Diplopia Aseptic meningitis Drug interaction with divalproex increases lamotrigine; with carbamazepine, phenytoin decreases lamotrigine levels Concomitant use with oral contraceptives decreases lamotrigine levels Withdrawal seizures Dermatologic evaluation at baseline and patient education regarding reporting of new skin rash Page 8
Mood Stabilizer Medications Oxcarbazepine Trileptal Not FDA approved for bipolar disorder or mood lability in children and adolescents* FDA approved for seizures ages 4 and older Hyponatremia risk Anaphylactic reactions with angioedema Drug-drug interaction potential Dizziness, ataxia Diplopia Tremor Slurred speech Serious dermatologic reactions Withdrawal seizures Multi-organ hypersensitivity Hematologic changes * While difficult to establish a definitive diagnosis of bipolar disorder in children and adolescents, the mood stabilizing antiepileptic agents listed, while not FDA approved for use in children and adolescents, do have some body of published evidence based support and have received FDA approval for seizure disorder management, suggested a reasonable safety margin for that use. Electrolytes at baseline and every 3-6 months Comprehensive chemistry panel includes: electrolytes, renal and hepatic function, and metabolic panel Page 9
Diphenhydramine Benadryl Approved for children 12 and older for the treatment of insomnia Sleep Medications None Drowsiness Dizziness Dry mouth Nausea Nervousness Blurred vision Decreased mental alertness Paradoxical excitation May lower seizure threshold Trazodone* Desyrel 18 and older None Abnormal generalized bleeding risk Hyponatremia Stomach discomfort Flu-like symptoms if stopped too quickly Orthostatic hypotension/syncopy Cognitive/motor impairment Priapism-males QT prolongation and risk of sudden cardiac death Eszopliclone* Lunesta 18 and older None Abnormal thinking and al changes Withdrawal effects Drug abuse and dependence Tolerance Caution Assess compliance with avoiding operation of machinery or power equipment until medication effects with use of this medication are determined Daytime sedation/hangover Seizure risk with other medications Weight Blood pressure baseline and periodically EKG baseline and periodically Caution - Do not operate machinery or power equipment until medication effects with use of this medication Daytime sedation/hangover Page 10
Melatonin Dosing: 0.05-0.15mg/kg/day up to total dose of 5mg/day in children and adolescents Not FDA regulated Sleep Medications Regulated by FDA as a dietary supplement and not as a medication Sedation May adversely affect reproductive organ development Give directly before sleep onset desired due to short half-life Ramelteon* Rozerem 18 and older None Abnormal thinking and al changes CNS depression Decreased testosterone Hyperprolactinemia Hydroxyzine Vistaril, Atarax All ages for anxietyand all ages for Pruritis/ for the treatment of Itchy skin- *not approved as a sedative/hypnotic in children and adolescents Approved for anxiety and tension; approved as preprocedural sedation and following general anesthesia Drowsiness Dizziness Dry mouth Nausea Nervousness Blurred vision Decreased mental alertness Paradoxical excitation associated with small risk of QT prolongation and Torsades Caution - Do not operate machinery or power equipment until medication effects with use of this medication Daytime sedation/hangover Caution - Do not operate machinery or power equipment until medication effects with use of this medication Daytime sedation/hangover Caution - Do not operate machinery or power equipment until medication effects with use of this medication Daytime sedation/hangover Page 11
Appendix A: Color-Coded Psychotropic Medications - Match the Color with the Therapeutic Class Above Amphetamine Mixed Salts Eszopliclone Quetipine Abilify Fanapt Quillivant XR Adderall, Adderall XR Fetzima Ramelteon Anafranil Fluoxetine Remeron Aripiprazole Fluvoxamine Rexulti Asenapine Focalin, Focalin XR Risperdal Atomoxetine Geodon Risperidone Benadryl Guanfacine Ritalin, Ritalin SR/LA Brexpiprazole Hydroxyzine Rozerem Brintellix Iloperidone Saphris Bupropion Invega Seroquel, Seroquel XR Carbamazepine Lamictal Sertraline Catapres, Kapvay Lexapro Strattera Celexa Lithium Page 12 Tegretol, Tegretol XR, Epitol, Carbatrol, Equetro Citalopram Lixdexamfetamine Tenex, Intuniv Clomipramine Lamotrigine Trazodone Clonidine Latuda Trileptal Clozapine Levmilnacipram Trintellix Clozaril, FazaClo, Versacloz Lunesta Venlafaxine Concerta Lurasidone Vibryd Cymbalta Luvox Vilazodone Depakote, Depakote ER, Depakote Sprinkles Melatonin Vistaril, Atarax Desvenlafaxine Metadate ER, Metadate CD Vortioxetine Desyrel Methylin, Methylin ER Vyvanse Dexedrine, Zenzedi Methylphenidate Wellbutrin, XL/SR Dexmethylphenidate Mirtazapine Ziprasidone
Appendix A: Color-Coded Psychotropic Medications - Match the Color with the Therapeutic Class Above Dextroamphetamine Olanzapine Zoloft Diphenhydramine Oxcarbazepine Zyprexa Divalproex Sodium Duloxetine Effexor, Effexor XR Escitalopram Eskalith, Eskalith CR, Lithobid Paliperidone Paroxetine Paxil Pristiq Prozac Page 13
Appendix B: Questions to Ask the Prescriber 1. Are there al interventions that might be tried before medication is used, or effectively used in combination with medication, which may help to lower the required medication dose? 2. Does research support the use of the recommended medication for a child that is my child s age and with similar needs? 3. How does medication fit within the overall treatment plan and how will we coordinate with other treatment, such as therapy, school plans, and more? 4. Is the prescribed medication more, less, or equally effective as other non-medicinal interventions? 5. What should we be looking for in changes in, changes in symptoms, and whom should we contact with questions about these changes and the medication? 6. How long will it take before we should begin seeing al changes? Will those potential changes be significant or minor? 7. What are the potential risks and benefits of the medication and other treatment options, and what are the potential side effects? 8. If a medication dose is missed or stopped abruptly, are there potential adverse effects? What might those be and what should I do if I observe them? 9. How will our family, our child, and the treating provider monitor progress, changes, symptoms, and safety concerns? (Close monitoring is critical with all medications at all times, however, it is especially important when medication is started and when dosages are changed.) 10. How will we know when it is time to talk about stopping medication treatment and what steps need to be taken before the medication is stopped? 11. How can we best develop a clear communication plan between our family and the treating providers (therapist and psychiatrist) to ensure open lines of communication? 12. What if my child has a crisis and is hospitalized? Who can we contact in your office, especially if someone wants to change medications? Adapted from NAMI, Choosing the Right Treatment: What Families Need to Know about Evidence-Based Practices, 2007. Page 14
Appendix C: Glossary of Terms BMI CBC Discontinuation Syndrome ECG EEG EPS ER Evidence Based Use FDA Hemoglobin A1c Hepatic Toxicity Hyperammonemia Hyponatremia Indication IR LFTs MAOIs Stands for Body Mass Index. A measure of body fat based upon height and weight. Stands for complete blood count. Lab test used to monitor for abnormalities in blood cells, e.g., for anemia. A condition that can occur following the interruption, dose reduction, or discontinuation of antidepressant drugs. The symptoms can include flu-like symptoms and disturbances in sleep, senses, movement, mood, and thinking. In most cases symptoms are mild, short-lived, and go away without treatment. Stands for electrocardiogram. Stands for electroencephalogram. Stands for extrapyramidal side effects- medication induced abnormal muscle function and include muscle stiffness, tremor, facial tics/movements, and severe muscle spasm. Stands for extended release and is a formulation of a medication designed to decrease the number of times per day in which the medication must be taken. Substantial peer reviewed clinical trials information is in the published medical literature supporting the safety and effectiveness of a certain practice or medication use. Stands for (U.S.) Food and Drug Administration, the agency which reviews and approves medications for use in the United States. A laboratory measurement of the amount of glucose in the hemoglobin of the red blood cells. Provides a measure of average glucose over the previous 3 months. Liver damage which may be happen from a variety of potential causes. Metabolic problem due to elevated ammonia in the blood and is a medical emergency. A condition of low blood sodium (Na) levels which may be associated with a number of medical symptoms such as decreased ability to think, headaches, nausea, and poor balance. More severe symptoms include confusion, seizures, and coma. A term that means the FDA has approved a medication for use for a specific purpose and age group. Stands for immediate release of a form of a medication. May be necessary to take multiple times per day. Stands for Liver function tests. Stands for Monoamine Oxidase Inhibitors. A class of medications used for depression. Page 15
MRI Narrow Therapeutic Index Drug Orthostatic Blood Pressure Changes PRN Prolactin Second Generation Antipsychotics Serum Creatinine Teratogenicity TFTs Stands for Magnetic Resonance Imaging. A medication for which the safe and effective range (as measured by blood levels) are close to the toxic range (e.g. lithium, carbamazepine, phenytoin). Lowering of blood pressure, typically upon sitting up or standing, which may be related to some medications and may contribute to falls and/or accidents. A term that means the medication should be taken as needed. A hormone produced by the pituitary gland. A classification of antipsychotics which are more often used in children and adolescents as compared to first generation antipsychotics which are more commonly associated with abnormal neurologic movements. A lab test used to calculate an estimate of kidney function. Property of some medications meant to indicate that they are may potentially cause abnormalities in the developing fetus. Thyroid Function Tests. Page 16